Good afternoon. My name is Annie, and I will be your conference operator today. At this time, I would like to welcome everyone to Geron Q2 2019 Earnings Conference Call. [Operator Instructions]. Thank you. I would now like to turn the call over to Ms. Suzanne Messere, Investor Relations. You may begin the call, ma'am.

Thank you, Annie, and good afternoon, everyone. Thank you for joining us for our second quarter conference call. I'm joined today by Dr. John Scarlett, Geron's Chairman and Chief Executive Officer; and Olivia Bloom, the company's Chief Financial Officer. Dr. Aleksandra Rizo, our Chief Medical Officer, is with us today as well and will be available during the Q&A portion of the call. After the market closed, we announced our second quarter 2019 financial results via press release. It is available on our website under www.geron.com/investors. In the press release, we also provided an update on the Phase III portion of IMerge. This afternoon, management will discuss the information from today's press release. A live webcast of the call is available on our website and will be archived for 30 days. Before we begin, please note that except for statements of historical fact, this presentation and question-and-answer session contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements include any of the company's plans, expectations, timelines, beliefs, statements of potentiality and projections and without limitation, those regarding that the Phase III portion of IMerge is planned to open for patient screening and enrollment in August 2019. That statistical analysis of IMbark data and real-world data suggest potential favorable overall survival and a lower risk of death with imetelstat myelofibrosis treatment; that there will be an end of Phase II meeting with the FDA by the end of the first quarter 2020; that Geron will potentially develop imetelstat for relapse/refractory MF patients; and that Geron's 2019 operating expenses will be in the range of $80 million to $85 million. All of these forward-looking statements involve risks and uncertainties that can cause actual results to differ…

Thanks, Suzanne, and good afternoon, everyone. In this last quarter, we continued to achieve our 2019 milestones and advanced the development of imetelstat. We remain on schedule with our previously communicated timelines. Completion of the IND transfer in May was an important step to enable us to accelerate our startup activities for the planned Phase III portion of IMerge. As a reminder, the Phase III portion of IMerge is designed as a randomized, double-blind, placebo-controlled clinical trial to test the hypothesis that imetelstat improves the rate of transfusion independence compared to placebo. Approximately, 170 patients are planned to be enrolled and randomize in a 2:1 ratio to receive, either imetelstat or placebo. Many key aspects from the Phase II portion of IMerge will remain the same for the Phase III portion. During the Phase II, a target patient population of non-del(5q), lower-risk MDS patients who were relapsed after or refractory to treatment with an EFA and naive to treatment with hypomethylating agents and lenalidomide were identified. The same target patient population will be enrolled in the Phase III portion of the study. In addition, the primary and secondary endpoints, the dose and schedule of imetelstat administration and many other clinical sites will remain the same in Phase III. We plan that the trial will be conducted at multiple medical centers globally, including North America, Europe, Middle East and Asia. We expect the trial to be initiated upon the opening of screening enrollment later this month and plan to issue a press release at the time that occurs. In addition to the clinical operational activities that have been underway this past quarter, at the 24th European Hematology Association Annual Congress in June, we also reported compelling data from the Phase II portion of IMerge and new statistical analyses of the overall survival data from IMbark in comparison to real-world data. I'll highlight key aspects of these presentations later on the call. Both of these data presentations provide further support of our clinical plans, including the start of the Phase III trial in lower-risk MDS and further evaluation of the potential for late-stage development of imetelstat in relapsed/refractory MF. We couldn't have accomplished all of this without having recruited the right team to execute our development plans. Our recent hiring of Vice President of Global Regulatory Affairs further expands our development leadership group, and it brings our total development team headcount to 16. We now have an in-house multifunctional development team that has deep relationships within the oncology community and great expertise in late-stage hematology-oncology drug development. We credit a strong belief in imetelstat's future potential as being a key driver for such top talent to decide to join Geron. Now I'd like to turn the call over to Olivia, our CFO, who will review financial results for the second quarter. Olivia?

Thank you, Chip, and good afternoon, everyone. For the second quarter of 2019, we reported a net loss of $14.2 million or $0.08 per share compared to $6.9 million or $0.04 per share for the comparable 2018 period. Net loss for the first six months of 2019 was $24.3 million or $0.13 per share compared to $14.1 million or $0.08 per share for the comparable 2018 period. Revenues for the three and six months ended June 30, 2019, were $101,000 and $158,000, respectively, compared to $208,000 and $526,000 for the comparable 2018 period. Revenues for the three and six months ended June 30, 2019 and 2018 included royalty and licensee revenues under various non-imetelstat license agreements. The decrease in licensee and royalty revenues compared to the same periods in 2018 reflect a reduction in the number of active research license agreements in 2019 related to our human telomerase reverse transcriptase, or hTERT, technology as a result of patent expirations on the underlying technology. Total operating expenses for the three and six months ended June 30, 2019, were $15.3 million and $26.7 million, respectively, compared to $7.5 million and $15.2 million for the comparable 2018 periods. Research and development expenses for the three and six months ended June 30, 2019, were $10.1 million and $16 million, respectively, compared to $3.2 million and $5.6 million for the comparable 2018 periods. The increase in research and development expenses compared to the same periods in 2018, primarily reflects cost for the transition of the imetelstat program, including resuming sponsorship of the ongoing imetelstat clinical trial, higher personnel-related costs for the expanding development team and expenses for the startup activities for the Phase III portion of IMerge. General and administrative expenses for the three and six months ended June 30, 2019, were $5.2 million and…

Thanks, Olivia. I'll finish today's discussion with highlights from the data presentations in June at the EHA Annual Congress. As you know, we also hosted the KOL event on June 25 with two of the investigators who reprised the EHA presentations and participated in the question-and-answer session with sell-side analysts. We were encouraged by the interactive dialogue at the KOL event that discussed the significant unmet medical need in both lower-risk MDS that's relapsed and refractory to ESAs as well as in relapsed/refractory MF, and the important role imetelstat can potentially serve in meeting those needs. For lower-risk MDS, Dr. Platzbecker emphasized the meaningful and durable transfusion independence, broad activity and disease modifying potential of imetelstat treatment. For relapsed/refractory MF, Dr. [indiscernible] described how real-world data corroborated the potential OS benefit with the imetelstat treatment that's been observed in IMbark. So now I'd like to review the highlights. First, let's review the updated efficacy and safety data from the 38 target population patients in the Phase II portion of IMerge. The data cutoff date for the presentation at EHA was April 30, 2019, at which time the median follow-up was 15.7 months. As a reminder, IMerge is a two part Phase II/III clinical trial. The primary efficacy endpoint is an eight week TI rate, or simply stated, the proportion of patients who achieved transfusion independence or TI for a period of eight consecutive weeks. Key secondary endpoints include the rate of TI lasting at least 24 weeks or 24-week rate TI and duration of TI. The EHA presentation of the updated IMerge data reported meaningful and durable transfusion independence achievable with imetelstat treatment in heavily transfusion-dependent, lower-risk MDS patients. The importance of all of these was emphasized by both investigators who participated in the KOL event. In particular, the clinically…

[Operator Instructions]. Our first question is from Chad Messer from Needham.

I was wondering if you could talk a little bit more about what you're doing to prepare for the end of Phase II meeting that you hope to have in the first quarter. I know you've brought in some KOL, you've been having discussions. Sort of what's the emerging story you think you need to get in there and tell the FDA about imetelstat in these patients? What data do you think it's important to emphasize? And kind of what questions you -- do you hope to get answered?

Chad, we have been pretty resolute in not discussing the content of the specifics of analyses that we're doing or really the kinds of specific questions that we'll be asking the FDA. I think that's really both confidential information and also best shared with the regulators before we share them with everyone else. So I think I'm going to -- unfortunately have to demur. I can certainly tell you that a successful meeting would be where we gain insights into how the FDA views potential registration strategies for imetelstat. But exactly how we're preparing for that discussions, I think, has to remain uncommented on at this point in time.

All right. That's fair enough. I've known you long enough to respect your conservatism on issues like that. Maybe one just for Olivia then. How -- what is still available to you on your aftermarket?

On our aftermarket, it's -- approximately $57 million is still available.

We have another question from the line of Tom Shrader.

I have a question, a little bit related to Chad's question. But the recent guidance CTI got where they basically have a pivotal trial, and it's a straight spleen end point. Is that a complexity for you? Or do you think the drugs are so different that it's kind of irrelevant?

Tom, thanks for the question. I think that they are very different drugs. Both the mechanism of action are quite different. We know that JAK inhibitors in general are -- seem to have an activity against spleen size. And we have the potential disease-modifying activities that we've talked about, which may or may not be represented as well in just the pure spleen size but certainly, we believe, have a potential role or a potential overall survival benefit and also other activities. So I don't -- I think that's about probably all I can say right now about it. And I'll just say they are quite different drugs. And I think regulators probably look at them or we hope they’ll look at them as different drugs, maybe I'll say.

All right. Okay. Perfect. And then a question on IMerge. Based on your prior data, you've focused on patients that are HMA and lenalidomide naive. Do you have any sort of sense why those drugs interfere? Are they -- is there any -- they seem very different drugs and that prior treatment shouldn't matter. Or is it just sort of a general effect that if you've gone through HMA as your bone marrow was even more beat up, is there any sort of logical toehold to why you've chosen that group? I know the data tells you to, but I'm just looking for some mechanistic underpinning.

So I think you actually hit on an important one. I'll say the way I think about it's sort of a two-fold issue. The first one is that in the current treatment paradigm, patients who -- patients when they get the HMAs and for that matter, lenalidomide and non-del(5q) patients where it's not even -- lenalidomide, Revlimid isn't even approved, they're really pretty far along in the course of their disease. So I think right there, that's probably an important concept as we both know and oncology in general the further down the therapeutic spectrum you go usually the sicker the patients and the more resistant to treatment in general. I think the second is exactly as you said, all of these drugs exert some degree of toxicity, and HMAs certainly have substantial toxicity, including bone marrow toxicity. So I think it's probably a combination of both of those things.

Would you say that's well enough accepted, your second point that maybe physicians would be steered away from trying HMA or Revlimid first? Is that obvious? Is it something you hope to be the case? Just where does that fall on the current standard?

When we've talked to physicians, both in formal market research and also anecdotally, I think they would all love to have something before they have to go to HMAs or to an off-label drug like Revlimid. And HMAs are off-label in Europe as well, just to be clear. They are on label in the U.S. So I think they really like to have something that they could turn to first. And if there was a compelling story, which I think we believe is developing for imetelstat in patients before they get to HMAs or Revlimid, I think all of our market research suggests they'd be very excited and pretty thrilled to have that. So I don't think it's a matter that they feel like they have to trudge through HMAs and lenalidomide. It's simply they don't have anything else today really available to speak of. So that's the way I view it at least.

We do have another question from the line of Wayne Wu [ph] from B. Riley FBR.

So I have a question for about the IMerge Phase III trial. So the primary endpoint of IMerge Phase III is eight week TI rate and 24-week TI rate. And the quality of life is correlated with the frequency of RBC transfusions. Key secondary endpoint is the amount in relative changing the RBC transfusion, particularly since your patients are heavily transfusion-dependent. So how much weight does this secondary endpoint have with the regulators? And was it considered a [co] [ph] primary endpoint?

You want to -- Aleksandra might want to comment.

Sure. I can comment on that. Let me clarify first that the study has one primary endpoint and that is the eight week TI rate. So just to make that clarification straightforward, first. Then yes, key secondary endpoints are 24-week TI rate, and we know that regulators specifically are looking for durable TIs, which is something that we seem to offer from the Part 1 data as we know. And then yes, the quality of life. It's always very important, especially in terms of reimbursement path down the road. And that will be as well analyzed and looked into in our study as well.

All right, everyone, this ends our question-and-answer session for the call. I would now like to turn back the call over to Dr. Scarlett.

Well, thanks, everybody, for joining us today. We look forward to sharing more progress on our next quarterly call. Thank you. Have a good day.